Immix Biopharma Expands U.S. Sites for AL Amyloidosis Trial NEXICART-2

Immix Biopharma, Inc., a clinical-stage company dedicated to advancing cell therapies for AL Amyloidosis and other severe illnesses, has announced significant progress in its NEXICART-2 clinical trial in the United States. The company revealed that 14 sites are actively enrolling patients in this trial, marking an increase of 10 sites since its last update. This expansion is expected to accelerate the completion of the study, potentially ahead of schedule.

The CEO of Immix Biopharma, Dr. Ilya Rachman, expressed pride in the expansion of the clinical trial, highlighting the involvement of numerous national AL Amyloidosis centers. Gabriel Morris, the CFO, echoed this sentiment, stating that collaboration with these esteemed institutions positions the company to meet or exceed its timeline for the study's completion.

The NEXICART-2 trial is a Phase 1/2 study focusing on the sterically-optimized CAR-T therapy, NXC-201, designed for patients with relapsed or refractory AL Amyloidosis. This ongoing trial is set to enroll 40 participants who maintain heart function and have not previously undergone BCMA-targeted therapies. The primary goal of Phase 1 is to assess safety, while Phase 2 will evaluate efficacy.

The innovative NXC-201 therapy incorporates a "digital filter" feature to prevent non-specific activation, offering a promising treatment avenue for this challenging condition. The interim readout data from the U.S. trial has been selected for presentation at the prestigious 2025 American Society of Clinical Oncology Annual Meeting in Chicago. This presentation will be led by Dr. Heather Landau, a distinguished specialist in amyloidosis and bone marrow transplantation at Memorial Sloan-Kettering Cancer Center.

NXC-201 has garnered significant recognition, having been awarded Regenerative Medicine Advanced Therapy (RMAT) status by the FDA, as well as Orphan Drug Designation both in the United States and the European Union. These accolades reflect its potential impact on treating AL Amyloidosis, a condition arising from abnormal plasma cells that produce misfolded proteins. These proteins accumulate in various organs, causing severe damage and high mortality rates due to organ failure.

The prevalence of relapsed/refractory AL Amyloidosis in the United States is growing at a rate of 12% annually, with projections estimating 33,277 affected patients by 2024. This increase underscores the urgent need for effective treatments.

The amyloidosis market has seen substantial growth, expanding from $3.6 billion in 2017 to a projected $6 billion by 2025. Immix Biopharma is well-positioned to contribute to this market through its pioneering approaches to cell therapy.

As a clinical-stage biopharmaceutical company, Immix Biopharma is focused on developing innovative treatments for AL Amyloidosis and other severe diseases. Its lead candidate, NXC-201, has shown promising results, including no neurotoxicity, suggesting potential applications for other serious conditions.

Through its robust pipeline and strategic collaborations, Immix Biopharma aims to address unmet medical needs and improve patient outcomes. The company's dedication to advancing therapeutics continues to drive its efforts in developing effective solutions for challenging health conditions.